BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060 HOMERUN PUMP

    MDR report key: 596069 · Received April 21, 2005

    Report

    Report Number
    6000001-2005-01265
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Date of Event
    April 4, 2005
    Report Date
    April 6, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE, LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN REPORTED PAT HAD OVERINDUSION OF TPN. TOTAL BAG 1600 WITH 96 OVERFILL. RATE OVER 11 HRS 1 HR RAMP UP AND DOWN. BAG INFUSED BEFORE RAN DOWN STARTED. 1696 INFUSED IN 10 HRS. NO PT REPORT OF PT ISSUE. NO ADDITIONAL PT INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP FRN BAXTER HEALTHCARE PTE, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN